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FDA Drug Application 021172 by NOVO NORDISK INC

Application Number021172
Application Type New Drug Application
Sponsor ApplicantNOVO NORDISK INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/1/2001N3036000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog_Approv.pdf 11/1/2001
AP011/1/2001N3037000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog_prntlbl.pdf 11/1/2001
AP011/1/2001N3038000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog.cfm 11/1/2001
AP05/3/2002SCP3034001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21172S001ltr.pdf 5/3/2002
AP05/3/2002SCP3035001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s1lbl.pdf 5/3/2002
AP02/25/2002SCM       
AP06/26/2002SCF3032003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21172s003ltr.pdf 6/26/2002
AP06/26/2002SCF3033003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s3lbl.pdf 6/26/2002
AP02/25/2002SCM       
AP02/25/2002SCS       
AP02/25/2002SCM       
AP03/5/2002SCS       
AP07/29/2002SCS       
AP011/18/2002SCP3030009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21172scp009ltr.pdf 11/18/2002
AP011/18/2002SCP3031009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172scp009_novolog_lbl.pdf 11/18/2002
AP011/19/2002SCS       
AP012/4/2002SCS       
AP010/8/2004SLR10414013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986s019,21172s013ltr.pdf 10/15/2004
AP010/8/2004SLR10420013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s019,21172s013lbl.pdf 10/15/2004
AP011/21/2005SE813147021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s021lbl.pdf 11/30/2005
AP011/21/2005SE813167021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021172s021ltr.pdf 11/30/2005
AP011/15/2005SLR13109023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021172s023ltr.pdf 11/18/2005
AP011/15/2005SLR13117023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s023lbl.pdf 11/18/2005
AP07/20/2007SCF17331034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021172s034ltr.pdf 7/24/2007
AP07/20/2007SCF17352034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021172s034lbl.pdf 7/24/2007
AP09/3/2008SLR20762038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf 9/9/2008
AP09/3/2008SLR20763039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf 9/9/2008
AP011/28/2008SLR21299043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021536s023,020986s053,021172s043ltr.pdf 11/28/2008
AP05/7/2009SLR22545044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021172s044,021536s024ltr.pdf 5/13/2009
AP05/7/2010SE225525045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021172s045,s049ltr.pdf 5/12/2010
AP05/7/2010SE225574045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf 5/17/2010
AP02/25/2015SLR41931046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021172Orig1s046,s063ltr.pdf 2/27/2015
AP02/25/2015SLR41998046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s046s063lbl.pdf 3/3/2015
AP05/7/2010SE825575049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf 5/17/2010
AP05/7/2010SE825526049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021172s045,s049ltr.pdf 5/12/2010
AP012/13/2012SLR34688051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021172s051lbl.pdf 12/18/2012
AP012/13/2012SLR34704051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021172Orig1s051ltr.pdf 12/19/2012
AP03/9/2013SLR35401053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021172Orig1s053ltr.pdf 3/12/2013
AP03/9/2013SLR35438053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021172s053lbl.pdf 3/12/2013
AP09/4/2014SCM       
AP02/25/2015SLR41999063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s046s063lbl.pdf 3/3/2015
AP02/25/2015SLR41932063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021172Orig1s046,s063ltr.pdf 2/27/2015
AP04/17/2015SLR42570064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021172Orig1s064ltr.pdf 4/20/2015
AP04/17/2015SLR42624064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s064lbl.pdf 4/22/2015




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